Multiple Ascending Dose Safety Study of ShK-186 (Dalazatide) in Healthy Volunteers

NCT02446340 | Completed Phase 1 DMC

• 1 other identifier: 186-02
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine safety outcomes in healthy volunteers after systemic administration of multiple ascending doses of dalazatide.

Conditions

Healthy

Keywords

ShK-186; dalazatide; Kv1.3; SHK

Outcome Measures

Primary Outcomes (1)

• Subjects with adverse events

  From randomization to Day 57 (14 time points)

Secondary Outcomes (5)

• Subjects with changes in vital signs

  From randomization through Day 57 (14 time points)

• Subjects with changes in symptom-directed physical examinations

  From date of randomization to day 57 (14 timepoints)

• Subjects with changes in 12-lead electrocardiograms

  From date of randomization to day 57 (5 timepoints)

• PK parameters

  pre-dose, 15 minutes post dose, 30 minutes post dose, 1 hour post dose, 2 hours post dose, 4 hours post dose, 8 hours post dose, 12 hours post dose

• Presence of specific anti-drug antibody

  From date of randomization through Day 57 (4 timepoints).

Study Arms (4)

dalazatide 5ug

EXPERIMENTAL

8 subjects, 6 given active agent and 2 given placebo

Drug: dalazatide; Drug: placebo

dalazatide 15ug

EXPERIMENTAL

8 subjects, 6 given active agent and 2 given placebo

Drug: dalazatide; Drug: placebo

dalazatide 30ug

EXPERIMENTAL

8 subjects, 6 given active agent and 2 given placebo

Drug: dalazatide; Drug: placebo

dalazatide 60ug

EXPERIMENTAL

8 subjects, 6 given active agent and 2 given placebo

Drug: dalazatide; Drug: placebo

Interventions

dalazatide DRUG

Different doses of drug, subcutaneous injection twice per week for a total of 9 doses.

Also known as: ShK-186

dalazatide 15ug; dalazatide 30ug; dalazatide 5ug; dalazatide 60ug

placebo DRUG

Placebo delivered via subcutaneous administration twice per week for a total of 9 doses

Also known as: Sub Q Placebo

dalazatide 15ug; dalazatide 30ug; dalazatide 5ug; dalazatide 60ug

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy normal male and female subjects, ages 18 to 45, inclusive;
• able to communicate and able to provide valid, written informed consent;
• within the body mass index (BMI) range of approximately 18.0 to 30.0 kg/m2, inclusive;
• minimum weight of 50 kg;
• willingness to remain totally abstinent or use adequate contraception; e.g., 2 of the following methods: hormonal contraceptive, intrauterine device, condom, diaphragm, and spermicidal gel/foam) in order to prevent pregnancy from the screening visit until 60 days after the follow-up visit. For men, the donation of sperm during this period is also prohibited.

You may not qualify if:

• the presence of clinically significant medical history as determined by the investigator.
• the history of clinically significant cardiac abnormalities or presence of clinically significant abnormality on 12-lead ECG.
• the history of pre-existing paresthesia or neuropathy;
• abnormalities on neurologic exam at screening or baseline
• the history of any cancer requiring systemic chemotherapy or radiation; individuals with a history of non-melanoma skin cancer, nonrecurring carcinoma in situ treated with laser or cryotherapy or cervical cancer-in-situ, resected surgically with no evidence of disease, may be accepted on a case by case basis at the discretion of the Investigator;
• the presence of acute infection or history of acute infection within 7 days prior to receipt of the study drug; additionally, oral temperature may not exceed 37.4°C at baseline;
• the presence of clinically significant laboratory abnormalities (chemistry panel of 20 analytes \[Chem-20; fasted 10-12 hours\], complete blood count \[CBC\], and urinalysis \[UA\]) as determined by the investigator;
• positive urine drug screen for drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, cotinine, tricyclic antidepressants and alcohol) at Screening or at Baseline.
• typical intake of more than 7 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
• a positive hepatitis screen (Hepatitis BsAg or anti-HCV) or positive Human Immunodeficiency Virus (HIV) antibody test ;
• a history of multiple drug allergies that are important in the view of the Investigator;
• any history of anaphylaxis or a history of allergy to a medication, diet, or environmental exposure (including bee stings) that are important in the view of the Investigator;
• participation in another clinical trial with receipt of an investigational product within 60 days of dose administration (or 5 half lives, whichever is longer);
• recent (within 1 year of Screening) history of illicit drug use;
• history of alcohol abuse that is important in the view of the Investigator

Sponsors & Collaborators

• Kineta Inc.: lead

Study Sites (1)

PRA International

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Interventions

Shk-186 peptide

Study Officials

• Shawn Iadonato, PhD

  Kineta Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: May 18, 2015
• Study Start: November 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 18, 2015

Record last verified: 2015-05

Locations

US (1)